Trial of CT38 for ME/CFS by Cortene Inc.: big claims being made...

until subgroups of patients have been clearly defined (in one of them the HPA-axis playing the real havoc) it is risky to enter into such an experience as it may disturb the 'illness-balance' enhancing the symptoms caused by dysfunctions in other bodily systems

very little substantial research on the HPA-axis in ME has been done up till now tho'
 
CT38 Trial: Postponed

From:
http://birdbeeme.com/cortene-trial-postponed/
21-09-2018
I have some bad news today. Unfortunately, the Cortene trial has been postponed. Yep. I was told they are changing something with the study and need to get approval from the FDA and the IRB once again before they can move forward. My guess is there was some kind of effect on the first patients who received the medicine and they are re-calibrating. I have been told to continue my protocol, doing the daily symptoms survey and the tests for cognitive function. My exercise stress test was canceled, which I feel a little bit relieved about. They are not sure when they will be able to pick up the study again. It could be weeks, could be months. Knowing the IRB and the FDA… I’m not going to keep my hopes up.

Anyway, they said they would keep me in the loop, I’ll keep you in the loop too.
As always, be well.
Jackie
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Snow Leopard said:
So she can't answer the one question we want the answer to. :wtf:
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I think the answer is there.

Q: When will the second phase take place?

A: If they decide the trial was successful and want to expand it to more locations and more patients it will likely happen after the fall or perhaps even next year. Unfortunately these things take so much time. Luckily if it does expand, more people will be able to participate next time! (fingers crossed!)
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Moderator note: threads merged.


Hi. I received this email last night from Cortene. I wanted to share it with you. Its given me some hope. I emailed a year ago to enquire about an update and am now on their mailing list. I posted on PR and was advised to put on here too, so i joined up to share:

Dear Friends of Cortene, We are writing to let you know we have just completed our clinical trail in ME/CFS earlier this week. As you may already be aware, the trial was based upon our theory that a single receptor was up-regulated in the brains of ME/CFS patients. It proposed a novel therapeutic approach, in which a short exposure to a novel peptide (CT38) was intended to down-regulate the receptor, leading to symptom improvement. Our small (n=14) trial utilized 3 treatments of CT38, at 4 different dose-levels (no placebo). While we understand you are anxious to hear about our observations, it would be premature to share these until the data has been thoroughly reviewed and analyzed. We anticipate it will take 1-2 months to complete our analysis and write up our findings. That said, we have found the data encouraging and believe they support moving toward a randomized, double blind, placebo controlled trial. This will require significant funding and we are currently pursuing various channels to support continued development. We look forward to sharing more details soon and thank you for your continued support and patience. Regards, Michael
 
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Hopeful1976 said:
Hi. I received this email last night from Cortene. I wanted to share it with you. Its given me some hope. I emailed a year ago to enquire about an update and am now on their mailing list. I posted on PR and was advised to put on here too, so i joined up to share
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Welcome to the forum!

I'm a bit suspicious of anything that looks like premature hype, but I guess we can see how the double-blind trial goes. Thanks for letting us know.
 
Sunshine3 said:
I don't think it's hype, these guys seem genuine. It's awful early days yet so no telling how it will go.
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Yes, they seem genuine. If there data is good they then have to climb that mountain of trying to raise the millions it takes to bring a new drug to market.
Even if they raise the money we won't see this drug for years. Were better off if we can find an existing drug and re-purpose it.
 
Even if it only works for some people with ME-CFS (given that there might be so many different causes for the symptoms, this may be expected) we should all be allowed to try it. It certainly can't be any worse than being made to do GET, which makes more people more ill than better! Or to do nothing. How could this drug be worse than that?! So even if just a minority were helped, we should all be allowed to try it, because surely it would be worth it for those people that it does help. But you know that will never happen.
 
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